New Silicone Breast Implant Approved by FDA


March 09, 2012

March 9, 2012 — The US Food and Drug Administration (FDA) today approved a new silicone gel–filled breast implant, bringing the number of such products in the United States to 3, but continued to warn that women who receive any of these implants require lifelong monitoring.

The new silicone breast implant, made by Sientra, is indicated to increase breast size in women aged 22 years and older, and to reconstruct breast tissue in women of any age.

Sientra's product joins 2 other silicone-filled implants made by Allergan and Mentor that are currently on the market.

The safety of silicone breast implants has come into sharp focus after the French version of the FDA recalled implants made by Poly Implant Prothese (PIP) in 2010. PIP had used a nonapproved, industrial-grade silicone that is more prone to ruptures and leakage. As many as 300,000 women worldwide received the implants, and roughly 2000 have lodged complaints about adverse events, which include 8 cases of cancer.

In December 2011, the French government offered to pay to have the PIP implants removed from 30,000 French women.

PIP folded in 2010, but the company's founder, Jean-Claude Mas, continues to make headlines. Now facing charges of causing bodily harm, as well as committing fraud, Mas was jailed earlier this week by French authorities for not paying his bail.

Silicone Breast Implants Are Not "Lifetime Devices"

Here in the United States, the FDA has sounded cautionary notes about silicone breast implants. Last year, it reported that 20% of women who receive implants for breast augmentation will need them removed within 10 years. That percentage goes up to almost 50% for women who receive implants for breast reconstruction. The agency advised women with silicone implants, but not saline-filled implants, to undergo magnetic resonance imaging for silent ruptures 3 years after implantation, and every 2 years afterward.

Nevertheless, the FDA deems the new Sientra implant and those from Allergan and Mentor as safe. "Data on these and other approved silicone gel–filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness," said William Maisel, MD, deputy director for science in the FDA's Center for Devices and Radiological Health, in a press release.

Dr. Maisel also reiterated the need for watchfulness.

"It's important to remember that breast implants are not lifetime devices," said Dr. Maisel. "Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery and recognize that long-term monitoring is essential."

The FDA's approval of the Sientra implant was based on 3 years of clinical trial data on 1788 women. Adverse events and outcomes, which resembled those for other silicone breast implants, included capsular contracture, reoperation, implant removal, asymmetry, and infection.

The agency attached a number of conditions to its approval of the new implant. Sientra must:

  • follow the 1788 women who participated in the clinical trials for 7 more years;

  • study 4782 women who receive the implant for 10 years for signs of long-term local complications such as capsular contracture, rheumatoid arthritis, and breast and lung cancer; and

  • conduct 5 case–control studies to evaluate the link between the silicone implants and rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

More information on today's FDA decision is available on the agency's Web site.


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